Achillion Pharma (ACHN) Announces Positive SVR12 Data for Odalasvir, AL-335, and Simeprevir Phase 3 in Genotype 1 HCV
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Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) announced that updated interim results were presented today in an ePoster describing a phase 2 study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) at the European Association for the Study of the Liver (EASL) Special Conference in Paris, France.
These results, updated to include expanded safety and efficacy data, were presented in the ePoster entitled "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment-naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." It reports that 100 percent of patients receiving treatment for as short as six weeks with a triple combination of once-daily (QD) AL-335 800mg and simeprevir (SMV) 75mg with 50mg every other day (QOD) of ODV achieved a sustained viral response 12 weeks after the completion of treatment (SVR12).
“Odalasvir has continued to show that it has the potential to shorten the treatment duration to as little as six weeks in combination with other direct acting antivirals for the treatment of HCV,” commented Dr. Milind Deshpande, president and chief executive officer of Achillion. “We now look forward to seeing confirmation of these impressive data in Janssen’s global development program.”
Summary of Phase 2 Study Design and Interim Results
This study was designed to determine the safety, pharmacokinetics, and efficacy of different dosing regimens containing ODV and AL-335, with or without SMV, in treatment-naïve patients with GT1 HCV infection for treatment durations of eight or six weeks.
Of the GT1 non-cirrhotic patients that received the triple combination of ODV, AL-335, and simeprevir 100 percent remained HCV RNA undetectable at SVR12 and all patients in cohort 1 achieved SVR24 (i.e., cohorts 1, 3, and 4; N=60, 20/cohort). Cohort 1 evaluated the triple combination of ODV (50mg QD), AL-335 (400mg QD) and simeprevir (100mg QD) for eight weeks, while cohorts 3 & 4 assessed ODV (50 mg QOD), AL-335 (800 mg QD), and SMV (75 mg QD) for eight and six weeks, respectively. In cohort 2, which assessed the dual combination of ODV (50mg QOD) and AL-335 (800mg QD) for eight weeks, 90 percent of subjects achieved SVR12 (N=20).
In all of these cohorts, the dosing regimens were generally well-tolerated. The majority of adverse events (AEs) were mild and the most commonly reported events were headache, fatigue, and upper respiratory tract infection. As previously reported in the abstract, there was one serious adverse event (SAE) in cohort 1 that resulted in premature discontinuation of all study drugs. This consisted of a Mobitz Type 1 2nd degree atrioventricular block and was deemed probably related to ODV and possibly related to AL-335 and simeprevir. The event was not associated with clinical or echocardiographic abnormalities, did not require any therapeutic intervention, resolved following treatment discontinuation, and the patient went on to achieve SVR24. No clinically significant laboratory, echocardiography, or ECG abnormalities (except the SAE) were reported.
Ongoing Phase 2 Triple Combination Development Program
The interim results from this phase 2 study confirmed the treatment duration and dose for each component of the triple combination (i.e., once-daily ODV 25mg, AL-335 800mg, and SMV 75mg for treatment durations of six and eight weeks). The development program will include a multi-center, randomized, open-label study that will enroll treatment-naïve and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and 6. In addition, the ongoing phase 2a study is assessing the triple combination in patients with or without compensated cirrhosis, and with HCV genotype 3 infection.
Further information on clinical studies can be found at www.clinicaltrials.gov. Study identifier: NCT02765490.
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